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    Human Factors Manager - Sunnyvale, United States - Intuitive Surgical

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    Job Description

    Primary Function of Position: The Human Factors Manager collaborates with team members, designers, and engineers. They also work with cross-functional partners to support Human Factors team development. The manager represents the Human Factors function in business units for safety, usability, and regulatory compliance. They support and ensure execution of Usability Engineering initiatives and process activities within product development teams.

    The Human Factors Manager drives product development teams, plans usability activities, and supports direct reports within the HF team. They collaborate with regulatory and design groups to ensure proper usability engineering strategy implementation.

    This Human Factors Manager role can be assigned to four business units at Intuitive. They include Digital, ION, Da Vinci Multiport RAS, and Da Vinci Single Port RAS. The manager will report to Senior Human Factors Leadership, supporting all business units.Roles and Responsibilities:

    Research:

    • Work with Human Factors Research partners to establish and support strategy for usability research within the BU.
    • Forecast planning and budgeting for needed research efforts with the business unit, including estimates for needed resources and equipment.
    • Plan and support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.

    Design:

    • Mentor and support HF team members in development of usability requirements driving user interface design, training and labeling.
    • Collaborate with cross-functional partners to ensure integration of usability engineering into design input.
    • Consistently advocate for clinical caregivers' safety and usability, balancing user needs with business needs. Advocate with empathy.

    Evaluate:

    • Plan and define budgeting and resource needs for usability evaluation and testing efforts within the Business Unit.
    • Support usability evaluations and tests, reporting to leadership during product development stages. The Human Factors Manager will oversee testing for all BU projects, from prototypes to formal validation tests. Testing will occur in both US and OUS market environments.
    • Engage with customers worldwide to collect design feedback professionally through usability testing and user research in complex workflows.

    Growth

    • Make sure usability engineering documentation is accurate, clear, and delivered on time for various projects. This includes task investigation, risk scrutiny, complaint summaries, use specifications, and test reports.
    • Synthesize complex information into internal communications and presentations for product teams and broader organization leadership audiences.
    • Prepare and review documents for regulatory submission. Support responses to questions as needed. Submit to agencies and notified bodies.

    Sustain and Improve:

    • Manage team efforts in complaints investigation from on-market products, update usability risk assessment, and escalate usability-related issues as necessary.
    • Stay updated on MDR regulations and best practices for medical device human factors. Advise management on improving internal processes and regulatory issues.

    Collaborate:

    • Manage the efforts required to create and update usability risk analyses for Intuitive Surgical products.
    • Represent Human Factors as the main contact for HF input in regulatory submissions and resolving project conflicts. This includes coordinating between teams with conflicting needs.
    • Plan and manage human factors efforts across projects involving several sub-systems.
    • Coordinate HF team's testing needs, supplies, and equipment. Work closely with Platform team leaders to prepare test articles. Replace "leaders" with "managers" in the above sentence.
    • Mentor human factors engineers. - Train interns and junior team members. - Teach usability engineering methods. - Share best practices in Intuitive product development.


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